SK bioscience secures WHO GMP approval via streamlined remote audit

SK bioscience's L HOUSE manufacturing facility in Andong, North Gyeongsang Province, which recently cleared a World Health Organization Good Manufacturing Practice quality review via a streamlined desk audit. Courtesy of SK bioscience

SK bioscience completed on Thursday a periodic World Health Organization Good Manufacturing Practice (WHO GMP) review through a documentary assessment alone, without an on-site inspection, at its Andong L HOUSE manufacturing facility, the company said.

According to the company, the three-year GMP review covered four WHO prequalification-approved vaccines: influenza vaccines SKYCellflu and SKYCellflu Quadrivalent, varicella vaccine SKYVaricella and typhoid vaccine SKYTyphoid.

WHO GMP inspections typically require visits to production sites to verify manufacturing and quality management systems in person.

For the Andong facility, the review was completed solely through submitted documentation, which SK bioscience said reflects WHO's confidence in the site's operations and quality systems.

The company said the outcome is also linked to the growing international credibility of Korea's pharmaceutical regulatory system following the designation of the Ministry of Food and Drug Safety as a WHO-Listed Authority.

Under WHO's Regulatory Reliance policy, the organization can draw on the inspection results and assessments of listed regulatory authorities to replace on-site inspections with documentary reviews in certain cases. The ministry supported the process by helping submit the documentation WHO requested, the company said.

SK bioscience said the Andong L HOUSE facility, which obtained European Union GMP certification in 2021, has passed inspections by multiple international regulators and health organizations.

The company recently signed its first international procurement contract for SKYCellflu, its self-developed influenza vaccine.

"The successful completion of this WHO documentary GMP review demonstrates that the GMP operations and quality management systems at our Andong L HOUSE facility meet internationally recognized standards," an SK bioscience official said.

This article was published with the assistance of generative AI and edited by The Korea Times.